Phase 3
Completed N=1,250
Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007)
Bacterial Infections · Virus Diseases
Source: ClinicalTrials.gov NCT01341639 ↗
Enrolled (actual)
1,250
Serious AEs
3.7%
Results posted
Apr 2019
Primary outcomePrimary: Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months — 98.36; 99.82; 100; 100 Percentage of participants
◆ Published Evidence
Established
34citations · ~4 / year
A Phase III Randomized, Double-blind, Clinical Trial of an Investigational Hexavalent Vaccine Given at Two, Three, Four and Twelve Months.
Summary
This study will determine whether participants who receive the vaccine V419 at 2, 3, 4, and 12 months of age have an acceptable immune response to the vaccine. The study will also determine whether the immune response to V419 is similar to that of participants who receive a licensed vaccine control.
Linked Publications
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A Phase III Randomized, Double-blind, Clinical Trial of an Investigational Hexavalent Vaccine Given at Two, Three, Four and Twelve Months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months |
98.36; 99.82; 100; 100; 99.82; 100 | — |
| PRIMARY Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months |
94.99; 99.81; 100; 99.81; 100; 100 | — |
| PRIMARY Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months |
98.36; 86.99; 99.81; 99.81; 100; 100 | < 0.001 sig |
| PRIMARY Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response Rates to Hepatitis B and Seroresponse to Pertussis Antigens Pt, FHA and PRN One Month After the Toddler Dose at 13 Months Old |
99.64; 99.06; 99.82; 98.49; 97.22; 99.81 | < 0.001 sig |
| SECONDARY Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old |
96.15; 94.86; 98.29; 97.64 | — |
| SECONDARY Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old |
96.15; 96.41; 94.86; 91.78; 98.28; 97.89 | < 0.001 sig |
| SECONDARY Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination |
98.9; 99.5; 98.5; 98.8; 92.1; 91.0 | — |
| SECONDARY Percentage of Participants Reporting Solicited ISRs From Day 1 to Day 5 After Any Vaccination |
69; 64.2; 73.6; 71.8; 56.9; 52.9 | — |
| SECONDARY Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination |
2.8; 2.7; 1.5; 0.8; 1.3; 2.0 | — |
| SECONDARY Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination |
85.4; 87.9; 63.9; 67.0; 87.9; 85.7 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy infants able to attend all study visits
- Parent(s)/legal representative able to read, understand, and complete study questionnaires
Exclusion Criteria
- History of congenital or acquired immunodeficiency
- Received or is expected to receive immunosuppressive agents or systemic immunomodulatory steroids
- History of leukemia, lymphoma, malignant melanoma, or myeloproliferative disorder
- Hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines or concomitant study vaccines
- Has any chronic illness that could interfere with study conduct or completion
- Received any immune globulin, blood, or blood-derived products since birth
- Received a dose of hepatitis B vaccine prior to the study
- Vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, Haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus, measles, mumps, rubella, or varicella vaccines, or any combination thereof
- Fever within 24 hours prior to enrollment
- Received any non-study vaccine within 30 days prior to enrollment, except for inactivated influenza vaccine, which is permitted 14 days or more prior to enrollment
- Has a coagulation disorder
- Has developmental delay or neurological disorder
- Participant or his/her mother has a medical history of hepatitis B surface antigen (HBsAg) seropositivity
- History of measles, mumps, rubella, varicella, Haemophilus influenzae type B, hepatitis B, diphtheria, tetanus, pertussis, rotavirus, invasive pneumococcal, or poliomyelitis infection
Data sourced from ClinicalTrials.gov (NCT01341639) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.